title: Topical use of recombinant human epidermal growth factor (EGF)-based cream to prevent radiation dermatitis in breast cancer patients: a single-blind randomized preliminary study.
abstract: BACKGROUND
  The purpose of this study was to assess the effectiveness of a recombinant human epidermal growth factor (EGF)-based cream for the prevention of acute radiation dermatitis in breast cancer patients receiving radiotherapy (RT).
  
  
  METHODS
  Between December 2012 and April 2013, 40 breast cancer patients who received postoperative RT were prospectively enrolled in this study and randomly assigned to receive human recombinant EGF-based cream (intervention group) or general supportive skin care (control group). The grade of radiation dermatitis and pain score were examined at weekly intervals during RT and 6 weeks after RT completion.
  
  
  RESULTS
  All patients completed the planned RT and complied well with instructions for applying the study cream and general supportive skin care. In the intervention group, radiation dermatitis of maximum grade 3, 2, and 1 developed in 3 (15%), 11 (55%), and 6 patients (30%), respectively. In comparison, in the control group, radiation dermatitis of maximum grade 3, 2, and 1 developed in 8 (40%), 10 (50%), and 2 patients (10%), respectively. The intervention group showed lower incidence of grade 3 radiation dermatitis than the control group (p=0.068 in univariate analysis and p=0.035 in multivariate analysis). There was no statistically significant difference in the maximal pain score between the two groups (p=0.934).
  
  
  CONCLUSIONS
  This single-blind randomized preliminary study showed that recombinant human EGF-based cream can have a beneficial role in preventing or minimizing radiation dermatitis in breast cancer patients. To confirm the results of our study, additional studies with a large sample size are required.
authors.affiliation: Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, Seoul, Republic of Korea E-mail : kongmoonkyoo@khu.ac.kr.
authors.forename: Moonkyoo
authors.initials: M
authors.lastname: Kong
authors.forename: Seong Eon
authors.initials: SE
authors.lastname: Hong
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000532:radiotherapy*; D016022:Case-Control Studies; D004815:Epidermal Growth Factor / Q000008:administration & dosage* / Q000494:pharmacology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011855:Radiodermatitis / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology; D011878:Radiotherapy / Q000009:adverse effects*; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000494:pharmacology; D056910:Republic of Korea / Q000453:epidemiology; D016037:Single-Blind Method
chemical_list: D011994:Recombinant Proteins; D004815:Epidermal Growth Factor